Statistical Design and Analysis of Stability Studies
Title | Statistical Design and Analysis of Stability Studies PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 351 |
Release | 2007-05-30 |
Genre | Mathematics |
ISBN | 1584889063 |
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
Statistical Design and Analysis in Pharmaceutical Science
Title | Statistical Design and Analysis in Pharmaceutical Science PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 581 |
Release | 2018-10-03 |
Genre | Mathematics |
ISBN | 1482273136 |
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Statistical Design and Analysis in Pharmaceutical Science
Title | Statistical Design and Analysis in Pharmaceutical Science PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 580 |
Release | 1995-02-22 |
Genre | Mathematics |
ISBN | 9780824793364 |
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Statistical Design and Analysis of Clinical Trials
Title | Statistical Design and Analysis of Clinical Trials PDF eBook |
Author | Weichung Joe Shih |
Publisher | CRC Press |
Pages | 240 |
Release | 2015-07-28 |
Genre | Mathematics |
ISBN | 1482250500 |
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu
Design and Analysis of Bioavailability and Bioequivalence Studies
Title | Design and Analysis of Bioavailability and Bioequivalence Studies PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 758 |
Release | 2008-10-15 |
Genre | Mathematics |
ISBN | 1420011677 |
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Title | Encyclopedia of Biopharmaceutical Statistics - Four Volume Set PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 4031 |
Release | 2018-09-03 |
Genre | Medical |
ISBN | 135111025X |
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Design and Analysis of Clinical Trials with Time-to-Event Endpoints
Title | Design and Analysis of Clinical Trials with Time-to-Event Endpoints PDF eBook |
Author | Karl E. Peace |
Publisher | CRC Press |
Pages | 618 |
Release | 2009-04-23 |
Genre | Mathematics |
ISBN | 1420066404 |
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation o